What happened
Shares of Arbutus Biopharma (NASDAQ: ABUS) were trading down by 12.6% as of 11:04 a.m. ET Tuesday. The decline came after the company announced that the Food and Drug Administration (FDA) had placed a clinical hold on its Investigational New Drug (IND) application for AB-101, its experimental chronic hepatitis B virus therapy.
So what
It's unknown at this point exactly why the FDA placed the clinical hold on AB-101. The clinical-stage biopharmaceutical company said that the FDA indicated that it would send an official letter with more details within 30 days.
The company had hoped to advance the oral PD-L1 inhibitor into phase 1 clinical testing quickly enough to report initial data on it in the second half of 2023. Arbutus said it no longer expects to meet that timeline.
This FDA decision put a speed bump in Arbutus' path after what had up until that point been a great year. The biotech stock was up 24% year to date prior to Tuesday's announcement.
Arbutus presented positive preclinical data for experimental COVID-19 therapy AB-343 at the International Conference on Antiviral Research in March. It also dosed the first patient in a phase 1 study evaluating AB-161, an experimental oral therapy that holds the potential to provide a functional cure for patients infected by the hepatitis B virus.
Now what
There should be plenty of developments for investors to watch with Arbutus in the coming months. The company expects to report data from its phase 1 study of AB-161 in the second half of 2023. It also plans to announce preliminary results from a phase 2a study evaluating AB-729, a nucleoside/nucleotide analog therapy, and Vaccitech's VTP-300 in treating hepatitis B virus in the second half of the year as well.
10 stocks we like better than Arbutus Biopharma
When our analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*
They just revealed what they believe are the ten best stocks for investors to buy right now... and Arbutus Biopharma wasn't one of them! That's right -- they think these 10 stocks are even better buys.
*Stock Advisor returns as of April 24, 2023
Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
